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Presentation - Phase 1 & BA/BE Process Flow

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Info Kinetics
Info Kinetics

Timelines, Regulatory Process

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Info Kinetics Sdn Bhd /Clinical Research Centre Connecting Research & People Phase 1 Study BA/BE Study May 2010 These materials are CONFIDENTIAL and PROPRIETARY and for your review only.  This presentation is subject to revision as required as new information is obtained. Please respect the sensitive nature of this document by limiting its distribution, protecting the contents and refraining from making additional copies.
Full Services Under One Roof Pantai Hospital Penang Data Management & Reporting Protocol Development BE Study Phase 1 Study IRB / IEC Applications Bioanalytical Regulatory Applications Subject/Patient
Request for Information (RFI)
Quality Milestones Info Kinetics is the first CRO is Pan-Asia to achieve ISO9001:2000 and OECD GLP accreditation 2003-2004 2005-2006 2007-2008 2009-2010 2001-2002 ,[object Object]
Inspected by German Federal Bureau
GCP Inspection by French regulatory authorities (Afssaps)
GCP Inspection from NPCB (renewal)
Migration to ISO9001:2008
Company Established
First BE Study performed.
Complied with ICH-GCP
First CRO to obtain ISO 9001:2000

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Presentation - Phase 1 & BA/BE Process Flow

  • 1. Info Kinetics Sdn Bhd /Clinical Research Centre Connecting Research & People Phase 1 Study BA/BE Study May 2010 These materials are CONFIDENTIAL and PROPRIETARY and for your review only.  This presentation is subject to revision as required as new information is obtained. Please respect the sensitive nature of this document by limiting its distribution, protecting the contents and refraining from making additional copies.
  • 2. Full Services Under One Roof Pantai Hospital Penang Data Management & Reporting Protocol Development BE Study Phase 1 Study IRB / IEC Applications Bioanalytical Regulatory Applications Subject/Patient
  • 4.
  • 5. Inspected by German Federal Bureau
  • 6. GCP Inspection by French regulatory authorities (Afssaps)
  • 7. GCP Inspection from NPCB (renewal)
  • 8. Migration to ISO9001:2008
  • 10. First BE Study performed.
  • 12. First CRO to obtain ISO 9001:2000
  • 13. Inspections from NPCB and HSA
  • 14. Achieved ISO/IEC 17025 accreditation.
  • 15.
  • 16. Bioanalytical Laboratory Over 70 validated methods (plasma) Over 40 validated methods (pharmaceutical) LCMS/MS (2) GCMS (2) RRLC / UPLC (6) Agilent OpenLab® Platform
  • 17. Pre-Study Timelines Timelines Financial & Legal Operations Sponsor Request for Information (RFI) 2 d CDA Feasibility Studies (Facility Audit) TCE 1 - 2 wks Accepts Proposal Study Agreement Indemnity 1 - 2 wks Protocol Writing Inform Consent Forms Case Report Forms Provide Working Stds Method Development & Validation (if not validated) [4-6 weeks] Provide Technical Dossier 4 - 6 wks Regulatory Application (CTIL) / (NMRR) IEC Application (Approval)
  • 18. Study Timelines Timelines Financial Operations Sponsor Ship IMP to Site Subject Screening & Recruitment 2 wks Study Period 1 (washout period) Study Period 2 Safety Follow-up Monitoring Visits 2 - 4 wks Bioanalysis 4 - 6 wks Data Management & Statistical Analysis 2 - 3 wks Report Writing & Study Closure 2 - 3 wks 12-16 wks
  • 19. Regulatory Applications The Malaysian Govt. is very supportive of Translational Research. Day -21 Day 7 Day 1
  • 20. IRB / IEC Applications Independent Ethics Committee (JPEC) – ICH GCP standards Day -21 Day 7 Day 1